CPS Direct

Main information

  • Trade name:
  • CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac, ventricular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac, ventricular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219168
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219168

St Jude Medical Australia Pty Ltd - CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac,

ventricular

ARTG entry for

Medical Device Included Class III

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

13/01/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

St Jude Medical Cardiac Rhythm Management

Division USA

15900 Valley View Court

Sylmar, California, 91342

United States Of America

Products

1. CPS Direct Universal Slittable Outer Guide Catheter - Catheter, cardiac, ventricular

Product Type

Single Device Product

Effective date

13/01/2014

GMDN

17613 Catheter, cardiac, ventricular

Functional description

The catheter is used to facilitate left heart lead delivery during CRT procedures. The catheter provides

access to the coronary venous system and act as a conduit for contrast medium, implantable coronary

leads or other devices. The package includes 1 outer catheter, 1 dilator and 2 valve bypass tools.

Intended purpose

The CPS Direct Universal slittable outer guide catheter is designed for intracardiac access of the venous

system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and

St Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids

where minimising blood loss is essential. In addition, the catheters can work with inner catheters as a

system.

Variant information

Shape (of tip) Extra Wide

Shape (of tip) Straight

Shape (of tip) Wide

Shape (of tip) 115°

Length (cm) 47-54

Shape (of tip) Right Side

Shape (of tip) 135°

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 08:17:02 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

10-11-2018

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8-11-2018

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31-10-2018

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30-10-2018

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Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

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Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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17-10-2018

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Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

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Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

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Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

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11-10-2018

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2-10-2018

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Despite medical advances, cancer remains the leading cause of death in France.  While active smoking, alcohol consumption and an unbalanced diet continue to be the main causes of cancer mortality, the environment has a real impact on the risk of cancer, although it remains difficult to assess.

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2-10-2018

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27-9-2018

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Europe - EFSA - European Food Safety Authority Publications

21-9-2018

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Europe - EFSA - European Food Safety Authority Publications

18-9-2018

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12-9-2018

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FDA - U.S. Food and Drug Administration

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

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Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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29-8-2018

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29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

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29-8-2018

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29-8-2018

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20-8-2018

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10-8-2018

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

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27-7-2018

Agathe Denéchère appointed Deputy Director General for General Affairs at ANSES

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20-6-2018

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19-6-2018

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

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6-6-2018

Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

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France - Agence Nationale du Médicament Vétérinaire

29-5-2018

Under Armour Inc. recalls Yard Low DT and Highland Yard DT Cleats

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24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

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FDA - U.S. Food and Drug Administration

24-5-2018

Three questions for Gilles Salvat, ANSES Managing Director General for Research and Reference

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France - Agence Nationale du Médicament Vétérinaire

2-11-2018

Check out @US_FDA's information on Direct-to-Consumer Tests:  https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test   for detecting genetic variants that may be associated with medication   metabolism? Learn more about the authorization:  https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

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FDA - U.S. Food and Drug Administration

17-9-2018

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

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FDA - U.S. Food and Drug Administration

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

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28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

10-8-2018

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy  https://go.usa.gov/xUHC6 

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy https://go.usa.gov/xUHC6 

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy https://go.usa.gov/xUHC6 

FDA - U.S. Food and Drug Administration

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

30-5-2018

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use disorder. #FDA MedicalDevice

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Alnylam Netherlands B.V.)

EU/3/11/857 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA) - Transfer of orphan designation - Commission Decision (2018)3398 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/10/T/02

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1745 (Novartis Europharm Limited)

EU/3/16/1745 (Novartis Europharm Limited)

EU/3/16/1745 (Active substance: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19) - Transfer of orphan designation - Commission Decision (2018)3146 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/087/16/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1266 (Novartis Europharm Limited)

EU/3/14/1266 (Novartis Europharm Limited)

EU/3/14/1266 (Active substance: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19) - Transfer of orphan designation - Commission Decision (2018)3145 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/187/13/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety